When conducting breast surgery for the removal of tumors, the usual procedure is to locate the position and depth of the tumor by use of palpation, ultrasound, mammogram, or other detection devices. With this information, the surgeon typically makes a shallow incision in the skin so as to pull away the skin from the underlying tissue and then proceeds with surgery through the opening in the skin and into the fat and breast tissue to reach the tumor and excise it.
In recent years, various surgical aids have been developed for reaching and excising tumors. For example, a garrote wire has been used that has a loop that can be inserted over and beneath the tumor. The garrote loop is heated to a temperature sufficient for searing the tissue and the loop is drawn tightly beneath the tumor so as to release the tumor from the rest of the breast. This enables the surgeon to lift the tissue that contains the tumor from the patient. Other improvements include the use of cylindrically shaped cutters that cut a core of tissue from the breast, with the core surrounding the tumor and then excising the core with the tumor contained in the core.
Breast conserving surgery is considered the most desirable surgical option for the majority of women with breast cancer and has become the standard of care for most women with breast cancer. Desirably, the incision should be made about the tumor with a clear negative margin of tissue about the tumor so as to make sure that the entire tumor is excised.
Typically, when the tissue has been removed from the body, a pathologist examines the tissue to determine the nature of the cancerous growth and particularly to determine if the tumor extends beyond the tissue removed from the patient, or if the clear negative margin of tissue about the tumor is not adequate. If a portion of the tumor has been left in the patient or if a clear margin about the tumor is not adequate, a reexcision must be made.
One option for achieving a clear margin would be to remove a much larger amount of tissue about the tumor, however this compromises the cosmetic outcome of a procedure which is intended to conserve the contour of the breast. In addition, excision of more tissue is likely to extend the time for healing and recovery. The risk of bleeding and infection is likely increased as well. Another option for achieving a clear margin is to simply wait for the final pathology report, typically available a few days later. If the tumor has not been completely removed, or if the margin of tissue about the tumor is not adequate, a reexcision can be done. A reexcision would usually be made about two weeks after the initial surgery. The reexcision rates in the published literature range between 15% up to more than 50% of the initial operations. Reexcision usually is demoralizing and a physical ordeal for the patient, let alone the costs, added recovery time, and added risks of a second procedure.
Accordingly, it would be desirable for both the patient and the surgeon to use a device and a process for more reliably detecting the tumor, isolating the tumor and then excising the tumor from the body, with the device and with the procedure forming a small opening in the breast tissue for excising the tumor with a comparatively small amount of surrounding normal breast tissue, and providing the ability to reexcise about the initial excision cavity to form clear negative margins of tissue about the side of the tumor before termination of the overall initial procedure.